Alexandra L Quittner1, Kristen K Marciel2, Matthias A Salathe3, Anne E O'Donnell4, Mark H Gotfried5, Jonathan S Ilowite6, Mark L Metersky7, Patrick A Flume8, Sandra A Lewis9, Matthew McKevitt9, A Bruce Montgomery9, Thomas G O'Riordan10, Alan F Barker11. 1. Department of Psychology and Pediatrics, Department of Medicine, University of Miami, Coral Gables, FL. Electronic address: AQuittner@Miami.edu. 2. Department of Psychology and Pediatrics, Department of Medicine, University of Miami, Coral Gables, FL. 3. Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Miami, Coral Gables, FL. 4. Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Georgetown University, Washington, DC. 5. Pulmonary Associates, Phoenix, AZ; University of Arizona, Phoenix, AZ. 6. Department of Medicine, Division of Pulmonary and Critical Care, Winthrop University Hospital, Mineola, NY. 7. Division of Pulmonary and Critical Care, University of Connecticut School of Medicine, University of Connecticut, Farmington, CT. 8. Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC. 9. Gilead Sciences, Seattle, WA. 10. Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Georgetown University, Washington, DC; Gilead Sciences, Seattle, WA; Seattle, WACardeas Pharma, Seattle, WA. 11. Department of Medicine, Division of Pulmonary and Critical Care, Oregon Health and Science University, Portland, OR.
Abstract
BACKGROUND: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first disease-specific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented. METHODS: Reviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N = 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N = 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N = 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1). RESULTS: Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. CONCLUSIONS: This interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.
BACKGROUND: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first disease-specific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented. METHODS: Reviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N = 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N = 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N = 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1). RESULTS: Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. CONCLUSIONS: This interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.
Authors: Emily Henkle; Timothy Aksamit; Alan Barker; Charles L Daley; David Griffith; Philip Leitman; Amy Leitman; Elisha Malanga; Theodore K Marras; Kenneth N Olivier; D Rebecca Prevots; Delia Prieto; Alexandra L Quittner; William Skach; John W Walsh; Kevin L Winthrop Journal: Ann Am Thorac Soc Date: 2016-09
Authors: Sharon D Dell; Margaret W Leigh; Jane S Lucas; Thomas W Ferkol; Michael R Knowles; Adrianne Alpern; Laura Behan; Anjana M Morris; Claire Hogg; Audrey DunnGalvin; Alexandra L Quittner Journal: Ann Am Thorac Soc Date: 2016-10
Authors: Jane S Lucas; Laura Behan; Audrey Dunn Galvin; Adrianne Alpern; Anjana M Morris; Mary P Carroll; Michael R Knowles; Margaret W Leigh; Alexandra L Quittner Journal: Eur Respir J Date: 2015-05-14 Impact factor: 16.671
Authors: Amanda R McCullough; Michael M Tunney; Alexandra L Quittner; J Stuart Elborn; Judy M Bradley; Carmel M Hughes Journal: BMC Pulm Med Date: 2014-07-01 Impact factor: 3.317
Authors: Amanda R McCullough; Cristín Ryan; Brenda O'Neill; Judy M Bradley; J Stuart Elborn; Carmel M Hughes Journal: BMC Health Serv Res Date: 2015-08-22 Impact factor: 2.655